EUCTR2021-004536-28-SE进行中（未招募）1 期
Vaginal administration of selective estrogen receptor modulator (Tamoxifen) treatment to improve sexual function for women with breast cancer. A randomized, double-blinded, placebo controlled longitudinal phase 3 study.
ppsala University, Department of Women's and Children´s Health0 个研究点目标入组 120 人开始时间: 2021年9月16日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Sexually active postmenopausal women with breast cancer and ongoing adjuvant antiestrogen treatment with aromatase inhibitors who are willing to participate in the study and give their written consent.
- •2. Postmenopausal women with at least 12 months of spontaneous amenorrhea, or women who have had surgical bilateral oophorectomy at least 6 weeks ago, or level of follicle stimulating hormone (FSH) > 40 mIU/mL.
- •3. Have a vaginal pH > 5.0 at screening.
- •5. Have estradiol levels below the detection level, < 20 pmol/l.
- •6. Have one moderate to severe vulvovaginal atrophy symptom on the FACT-B scale that has been identified by the subject as being the most bothersome to her.
- •7. Be judged by the principal investigator as being in otherwise good health. The medical evaluation findings must include:
- •a. A normal or clinically non-significant finding at physical examination.
- •b. A mean sitting systolic blood pressure =150 mm Hg and diastolic blood pressure =90 mm Hg at screening.
- •c. A normal or clinically non-significant finding at gynecological examination.
- •d. A normal mammography that has been performed within 36 months prior to initial dose of study medication.
- •e. Laboratory values within normal limits or with non-significant deviations from normal values.
- •8. Have an endometrial thickness of < 4 mm as determined by vaginal ultrasonography, in women with an intact uterus.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Postmenopausal women with breast cancer and ongoing adjuvant antiestrogen treatment with oral tamoxifen.
- •In addition, women meeting any of the following criteria will not be permitted to enter the study:
- •1. Have a history of cardiovascular disease or thromboembolic events.
- •2. Have a history of or ongoing hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, neurologic, psychological, or musculoskeletal disease or disorder that is clinically significant in the opinion of the principal investigator.
- •3. Have a history of endometrial hyperplasia, endometrial polyps, endometrial cancer, or ovarian cancer.
- •4. Have a history of undiagnosed vaginal bleeding.
- •5. Have an ongoing urogenital infection in spite of treatment at the randomization visit.
- •6. Have used estrogen alone or estrogen/progestin for any of the following time periods: a. Vaginal hormonal products (rings, creams, gels, vaginal suppositories) within 12 weeks prior to the screening visit;
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